# K033838: Titanium Toggle Button (S)

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Feb 13, 2004 after 65 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922559 (1992). 6 ancestors in all.
97 later devices descend from it; 3 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813581: Cruciate Ligament Button, Biomet, Inc. (1982) Summary page 1.
- K984550: Pre-Threaded Endobutton, Smith & Nephew, Inc. (1999) Summary page 1.
- K980155: Endobutton Continuous Loop, Smith & Nephew, Inc. (1998) Summary page 1.

## Most influential descendants
- K083070: Toggleloc System (2008), 94 descendants of its own
- K123341: Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex Proximal Biceps Button (2012), 52 descendants of its own
- K150768: JuggerKnot Soft Anchors (2015), 40 descendants of its own
- K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to (2013), 35 descendants of its own
- K180768: Arthrex SwiveLock Anchors (2018), 28 descendants of its own

## Recalls of this device
- Apr 24, 2008 · Not classified · Z-0582-2012: Six sizes of ToggleLoc, Artificial Ligament Fixation Device, have been manufactured with the suture pull hole drilled in the wrong location on the device. The ToggleLoc implant is deployed with a sutu

## Indications for use
Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

Source page: https://510kreport.com/device/K033838
Methodology: https://510kreport.com/methodology